A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Eli Lilly and Company159 enrolled

Overview

The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

159

Conditions

Type 2 Diabetes

Interventions

DulaglutideDRUG

Administered subcutaneously (SC)

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who have had a diagnosis of type 2 diabetes mellitus * Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening * Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 \[DPP-4\] inhibitors, sulfonylurea \[SU\], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs * Participants who have stable weight (±5%) ≥3 months prior to screening * Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Participants who have a diagnosis of type 1 diabetes * Participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening * Participants who have been previously treated with dulaglutide prior to screening * Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide) * Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening * Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities * Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy

Locations (25)

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.

Time frame: Baseline, Week 16

Secondary Outcomes

Percentage of Participants With HbA1c <7.0% or ≤6.5%

Percentage of participants whose HbA1c was \<7.0% or ≤6.5%. HbA1c \<7.0% is presented.

Time frame: Week 16

Change From Baseline in Fasting Serum Glucose (FSG)

The LS mean change from baseline in FSG was calculated using a REML based MMRM and adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c Group (\<8.5%, \>=8.5%) + insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.

Time frame: Baseline, Week 16

Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: prebreakfast blood glucose (BG), breakfast 2-hour postprandial blood glucose (PPBG), prelunch BG, lunch 2-hour PPBG, predinner BG, dinner 2-hour PPBG, and bedtime BG. LS mean was calculated with fixed effect test of analysis of covariance (ANCOVA) model and adjusted by, baseline value, treatment, baseline HbA1c Group (\<8.5%, ≥8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin).

Time frame: Baseline, Week 16

Change From Baseline in Body Weight

Data from ClinicalTrials.gov

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Adachi-ku, Japan

Chiba, Japan

Chiyoda City, Japan

Chuou-ku, Japan

Chūōku, Japan

Fuchū, Japan

Ichikawa, Japan

Isahaya, Japan

Kamakura, Japan

...and 15 more locations